81_FR_27227 81 FR 27140 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

81 FR 27140 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 87 (May 5, 2016)

Page Range27140-27143
FR Document2016-10559

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.

Federal Register, Volume 81 Issue 87 (Thursday, May 5, 2016)
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Notices]
[Pages 27140-27143]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-10559]



[[Page 27140]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0065]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Registration of Food Facilities Under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
provisions of the Agency's regulations that require registration for 
domestic and foreign facilities that manufacture, process, pack, or 
hold food for human or animal consumption in the United States.

DATES: Submit either electronic or written comments on the collection 
of information by July 5, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0065 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Registration of Food Facilities 
Under the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques,

[[Page 27141]]

when appropriate, and other forms of information technology.

Registration of Food Facilities Under the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002--21 CFR 1.230 to 
1.235 OMB Control Number 0910-0502--Extension

    The Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (the Bioterrorism Act) added section 415 to the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d), 
which requires domestic and foreign facilities that manufacture, 
process, pack, or hold food for human or animal consumption in the 
United States to register with FDA. Sections 1.230 to 1.235 of FDA's 
regulations (21 CFR 1.230 to 1.235) set forth the procedures for 
registration of food facilities. Information provided to FDA under 
these regulations helps the agency to notify quickly the facilities 
that might be affected by a deliberate or accidental contamination of 
the food supply. In addition, data collected through registration is 
used to support FDA enforcement activities and to screen imported food 
shipments. Advance notice of imported food allows FDA, with the support 
of the Bureau of Customs and Border Protection, to target import 
inspections more effectively and help protect the nation's food supply 
against terrorist acts and other public health emergencies. If a 
facility is not registered or the registration for a facility is not 
updated when necessary, FDA may not be able to contact the facility and 
may not be able to target import inspections effectively in case of a 
known or potential threat to the food supply or other food-related 
emergency, putting consumers at risk of consuming hazardous food 
products that could cause serious adverse health consequences or death.
    FDA's regulations require that each facility that manufactures, 
processes, packs, or holds food for human or animal consumption in the 
United States register with FDA using Form FDA 3537 (Sec.  1.231), 
unless exempt under 21 CFR 1.226 from the requirement to register. The 
term ``Form FDA 3537'' refers to both the paper version of the form and 
the electronic system known as the Food Facility Registration Module, 
which is available at http://www.access.fda.gov. Domestic facilities 
are required to register whether or not food from the facility enters 
interstate commerce. Foreign facilities that manufacture/process, pack, 
or hold food also are required to register unless food from that 
facility undergoes further processing (including packaging) by another 
foreign facility outside the United States. However, if the further 
manufacturing/processing conducted by the subsequent facility consists 
of adding labeling or any similar activity of a de minimis nature, the 
former facility is required to register.
    Information FDA requires on the registration form includes the name 
and full address of the facility; emergency contact information; all 
trade names the facility uses; applicable food product categories; and 
a certification statement that includes the name of the individual 
authorized to submit the registration form. Additionally, facilities 
are encouraged to submit their preferred mailing address; type of 
activity conducted at the facility; type of storage, if the facility is 
primarily a holding facility; and approximate dates of operation if the 
facility's business is seasonal.
    In addition to registering, a facility is required to submit timely 
updates within 60 days of a change to any required information on its 
registration form, using Form FDA 3537 (Sec.  1.234), and to cancel its 
registration when the facility ceases to operate or is sold to new 
owners or ceases to manufacture/process, pack, or hold food for 
consumption in the United States, using Form FDA 3537a (Sec.  1.235).
    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) 
amended section 415 of the FD&C Act in relevant part to require 
registrants for food facilities to submit additional registration 
information to FDA, and to require facilities required to register with 
FDA to renew such registrations biennially. Section 415(a)(2) of the 
FD&C Act, as amended by FSMA, also provides that, when determined 
necessary by FDA ``through guidance,'' a food facility is required to 
submit to FDA information about the general food category of a food 
manufactured, processed, packed or held at such facility, as determined 
appropriate by FDA, including by guidance. The modified food facility 
registration forms includes the following mandatory fields: (1) The 
email address for the contact person of a domestic facility and the 
email address of the United States agent for a foreign facility; (2) an 
assurance that FDA will be permitted to inspect the facility; and (3) 
specific food categories as identified in the guidance document 
entitled, ``Guidance for Industry: Necessity of the Use of Food Product 
Categories in Food Facility Registrations and Updates to Food Product 
Categories'' (section 415(a)(2) of the FD&C Act 21 U.S.C. 350d(a)(2)).
    Food Facility Registration, in conjunction with advance notice of 
imported food, helps FDA act quickly in responding to a threatened or 
actual bioterrorist attack on the U.S. food supply or to other food-
related emergencies. Food Facility Registration provides FDA with 
information about facilities that manufacture/process, pack, or hold 
food for consumption in the United States. In the event of an outbreak 
of foodborne illness, such information helps FDA and other authorities 
determine the source and cause of the event. In addition, the 
registration information enables FDA to notify more quickly the 
facilities that might be affected by the outbreak. See Interim Final 
Rule entitled, ``Registration of Food Facilities Under the Public 
Health Security and Bioterrorism Preparedness and Response Act of 
2002'' (68 FR 58894, at 58895; October 10, 2003).
    Implementation of the FSMA requirements described previously helps 
enable FDA to quickly identify and remove from commerce an article of 
food for which there is a reasonable probability that the use of, or 
exposure to, such article of food will cause serious adverse health 
consequences or death to humans or animals. FDA uses the information 
collected under these provisions to help ensure that such food products 
are quickly and efficiently removed from the market.
    Description of Respondents: Respondents to this collection of 
information are owners, operators, or agents in charge of domestic or 
foreign facilities that manufacture, process, pack, or hold food for 
human or animal consumption in the United States.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 27142]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of
  21 CFR section and/or section of FD&C      FDA form        Number of     responses per   Total annual     Average burden per response     Total hours
                   Act                        number        respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     New Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Domestic
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.230 to 1.233 and section     FDA 3537 \2\          11,080               1          11,080  2.7...........................          29,916
 415 of the FD&C Act.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Foreign
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.  Sec.   1.230 to 1.233 and section         FDA 3537          19,900               1          19,900  8.9...........................         177,110
 415 of the FD&C Act.
                                         ---------------------------------------------------------------------------------------------------------------
    New Facility Registration Subtotal..  ..............  ..............  ..............  ..............  ..............................         207,026
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Previously Registered Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updates under Sec.   1.234 and section          FDA 3537         118,530               1         118,530  1.2...........................         142,236
 415 of the FD&C Act.
Cancellations under Sec.   1.235........       FDA 3537a           6,390               1           6,390  1.............................           6,390
Biennial renewal of registration                FDA 3537         104,786               1         104,786  0.50 (30 mins.)...............          52,393
 required by section 415 of the FD&C Act.
                                         ---------------------------------------------------------------------------------------------------------------
    Updates, Cancellations, or Biennial   ..............  ..............  ..............  ..............  ..............................         201,019
     Renewals Subtotal.
                                         ---------------------------------------------------------------------------------------------------------------
        Total Hours Annually............  ..............  ..............  ..............  ..............  ..............................         408,045
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3537'' refers to both the paper version of the form and the electronic system known as the Food Facility Registration Module,
  which is available at http://www.access.fda.gov.

    This estimate is based on FDA's experience and the average number 
of new facility registrations, updates and cancellations received in 
the past 3 years. Based on this experience, we estimate the annual 
number of new domestic facility registrations will be 11,080. We 
estimate that listing the information required by the Bioterrorism Act 
and presenting it in a format that will meet the Agency's registration 
regulations will require a burden of approximately 2.5 hours per 
average domestic facility registration. We estimate that the FSMA-
required additional information for new facility registrations will 
require an additional 12 minutes (0.2 hour) per response for domestic 
facilities. The average domestic facility burden hour estimate of 2.7 
hours takes into account that some respondents completing the 
registration may not have readily available Internet access. Thus, the 
total annual burden for new domestic facility registrations is 
calculated to be 29,916 hours (11,080 x 2.7 hours).
    Based on FDA's experience, we estimate the annual number of new 
foreign facility registrations will be 19,900. We estimate that listing 
the information required by the Bioterrorism Act and presenting it in a 
format that will meet the Agency's registration regulations will 
require a burden of approximately 8.5 hours per average foreign 
facility registration. We estimate that the FSMA-required additional 
information for new facility registrations will require an additional 
24 minutes (0.4 hour) per response for foreign facilities. The average 
foreign facility burden hour estimate of 8.9 hours includes an estimate 
of the additional burden on a foreign facility to obtain a U.S. agent, 
and takes into account that for some foreign facilities the respondent 
completing the registration may not be fluent in English and/or not 
have readily available Internet access. Thus, the total annual burden 
for new foreign facility registrations is calculated to be 177,110 
hours (19,900 x 8.9 hours).
    Based on FDA's experience, we estimate that the average annual 
number of updates to facility registrations will remain unchanged at 
118,530 updates annually over the next 3 years. We also estimate that 
updating a registration will, on average, require a burden of 
approximately 1 hour, taking into account fluency in English and 
Internet access. We estimate that the FSMA-required additional 
information for updates will require an additional 12 minutes (0.2 
hour) per response. Thus, the total annual burden of submitting updates 
to facility registrations is calculated to be 142,236 hours (118,530 x 
1.2 hours).
    Based on FDA's experience, we estimate that the average annual 
number of cancellations of facility registrations will remain unchanged 
at 6,390 cancellations annually over the next 3 years. We also estimate 
that cancelling a registration will, on average, require a burden of 
approximately 1 hour, taking into account fluency in English and 
Internet access. FSMA did not change the required information for 
cancellations. Thus, the total annual burden for cancelling 
registrations is estimated to be 6,390 hours.
    We estimate that the new biennial registration required by FSMA, 
which will require the submission of certain new data elements and the 
verification and possible updating of other information rather than re-
entering all information, will require 30 minutes (0.5 hour) per 
response, including time for the new FSMA-required information. We 
estimate that, on an annualized basis, the number of biennial 
registrations submitted over the next 3 years will be 104,786. This 
estimate is based on the number of currently registered firms (209,573) 
divided by two. Thus, the total annual burden for biennial registration 
is calculated to be 52,393 hours (104,786 x 0.5 hours).


[[Page 27143]]


    Dated: May 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10559 Filed 5-4-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                  27140                           Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices

                                                  DEPARTMENT OF HEALTH AND                                  • If you want to submit a comment                   accordance with 21 CFR 10.20 and other
                                                  HUMAN SERVICES                                          with confidential information that you                applicable disclosure law. For more
                                                                                                          do not wish to be made available to the               information about FDA’s posting of
                                                  Food and Drug Administration                            public, submit the comment as a                       comments to public dockets, see 80 FR
                                                  [Docket No. FDA–2013–N–0065]                            written/paper submission and in the                   56469, September 18, 2015, or access
                                                                                                          manner detailed (see ‘‘Written/Paper                  the information at: http://www.fda.gov/
                                                  Agency Information Collection                           Submissions’’ and ‘‘Instructions’’).                  regulatoryinformation/dockets/
                                                  Activities; Proposed Collection;                        Written/Paper Submissions                             default.htm.
                                                  Comment Request; Registration of                                                                                 Docket: For access to the docket to
                                                  Food Facilities Under the Public Health                    Submit written/paper submissions as                read background documents or the
                                                  Security and Bioterrorism                               follows:                                              electronic and written/paper comments
                                                  Preparedness and Response Act of                           • Mail/Hand delivery/Courier (for
                                                                                                                                                                received, go to http://
                                                  2002                                                    written/paper submissions): Division of
                                                                                                                                                                www.regulations.gov and insert the
                                                                                                          Dockets Management (HFA–305), Food
                                                  AGENCY:    Food and Drug Administration,                                                                      docket number, found in brackets in the
                                                                                                          and Drug Administration, 5630 Fishers
                                                  HHS.                                                                                                          heading of this document, into the
                                                                                                          Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                             • For written/paper comments                       ‘‘Search’’ box and follow the prompts
                                                  ACTION:   Notice.
                                                                                                          submitted to the Division of Dockets                  and/or go to the Division of Dockets
                                                  SUMMARY:   The Food and Drug                            Management, FDA will post your                        Management, 5630 Fishers Lane, Rm.
                                                  Administration (FDA or we) is                           comment, as well as any attachments,                  1061, Rockville, MD 20852.
                                                  announcing an opportunity for public                    except for information submitted,                     FOR FURTHER INFORMATION CONTACT:    FDA
                                                  comment on the proposed collection of                   marked and identified, as confidential,               PRA Staff, Office of Operations, Food
                                                  certain information by the Agency.                      if submitted as detailed in                           and Drug Administration, 8455
                                                  Under the Paperwork Reduction Act of                    ‘‘Instructions.’’                                     Colesville Rd., COLE–14526, Silver
                                                  1995 (the PRA), Federal Agencies are                       Instructions: All submissions received             Spring, MD 20993–0002, PRAStaff@
                                                  required to publish notice in the                       must include the Docket No. FDA–                      fda.hhs.gov.
                                                  Federal Register concerning each                        2013–N–0065 for ‘‘Agency Information
                                                  proposed collection of information,                     Collection Activities; Proposed                       SUPPLEMENTARY INFORMATION:       Under the
                                                  including each proposed extension of an                 Collection; Comment Request;                          PRA (44 U.S.C. 3501–3520), Federal
                                                  existing collection of information, and                 Registration of Food Facilities Under the             Agencies must obtain approval from the
                                                  to allow 60 days for public comment in                  Public Health Security and Bioterrorism               Office of Management and Budget
                                                  response to the notice. This notice                     Preparedness and Response Act of                      (OMB) for each collection of
                                                  solicits comments on the information                    2002.’’ Received comments will be                     information they conduct or sponsor.
                                                  collection provisions of the Agency’s                   placed in the docket and, except for                  ‘‘Collection of information’’ is defined
                                                  regulations that require registration for               those submitted as ‘‘Confidential                     in 44 U.S.C. 3502(3) and 5 CFR
                                                  domestic and foreign facilities that                    Submissions,’’ publicly viewable at                   1320.3(c) and includes Agency requests
                                                  manufacture, process, pack, or hold                     http://www.regulations.gov or at the                  or requirements that members of the
                                                  food for human or animal consumption                    Division of Dockets Management                        public submit reports, keep records, or
                                                  in the United States.                                   between 9 a.m. and 4 p.m., Monday                     provide information to a third party.
                                                  DATES: Submit either electronic or                      through Friday.                                       Section 3506(c)(2)(A) of the PRA (44
                                                  written comments on the collection of                      • Confidential Submissions—To                      U.S.C. 3506(c)(2)(A)) requires Federal
                                                  information by July 5, 2016.                            submit a comment with confidential                    Agencies to provide a 60-day notice in
                                                  ADDRESSES: You may submit comments                      information that you do not wish to be                the Federal Register concerning each
                                                  as follows:                                             made publicly available, submit your                  proposed collection of information,
                                                                                                          comments only as a written/paper                      including each proposed extension of an
                                                  Electronic Submissions                                  submission. You should submit two                     existing collection of information,
                                                    Submit electronic comments in the                     copies total. One copy will include the               before submitting the collection to OMB
                                                  following way:                                          information you claim to be confidential              for approval. To comply with this
                                                    • Federal eRulemaking Portal: http://                 with a heading or cover note that states              requirement, FDA is publishing notice
                                                  www.regulations.gov. Follow the                         ‘‘THIS DOCUMENT CONTAINS                              of the proposed collection of
                                                  instructions for submitting comments.                   CONFIDENTIAL INFORMATION.’’ The                       information set forth in this document.
                                                  Comments submitted electronically,                      Agency will review this copy, including                  With respect to the following
                                                  including attachments, to http://                       the claimed confidential information, in              collection of information, FDA invites
                                                  www.regulations.gov will be posted to                   its consideration of comments. The                    comments on these topics: (1) Whether
                                                  the docket unchanged. Because your                      second copy, which will have the                      the proposed collection of information
                                                  comment will be made public, you are                    claimed confidential information                      is necessary for the proper performance
                                                  solely responsible for ensuring that your               redacted/blacked out, will be available               of FDA’s functions, including whether
                                                  comment does not include any                            for public viewing and posted on                      the information will have practical
                                                  confidential information that you or a                  http://www.regulations.gov. Submit                    utility; (2) the accuracy of FDA’s
                                                  third party may not wish to be posted,                  both copies to the Division of Dockets                estimate of the burden of the proposed
                                                  such as medical information, your or                    Management. If you do not wish your                   collection of information, including the
                                                  anyone else’s Social Security number, or                name and contact information to be                    validity of the methodology and
mstockstill on DSK3G9T082PROD with NOTICES




                                                  confidential business information, such                 made publicly available, you can                      assumptions used; (3) ways to enhance
                                                  as a manufacturing process. Please note                 provide this information on the cover                 the quality, utility, and clarity of the
                                                  that if you include your name, contact                  sheet and not in the body of your                     information to be collected; and (4)
                                                  information, or other information that                  comments and you must identify this                   ways to minimize the burden of the
                                                  identifies you in the body of your                      information as ‘‘confidential.’’ Any                  collection of information on
                                                  comments, that information will be                      information marked as ‘‘confidential’’                respondents, including through the use
                                                  posted on http://www.regulations.gov.                   will not be disclosed except in                       of automated collection techniques,


                                             VerDate Sep<11>2014   18:06 May 04, 2016   Jkt 238001   PO 00000   Frm 00058   Fmt 4703   Sfmt 4703   E:\FR\FM\05MYN1.SGM   05MYN1


                                                                                  Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices                                            27141

                                                  when appropriate, and other forms of                    at http://www.access.fda.gov. Domestic                includes the following mandatory fields:
                                                  information technology.                                 facilities are required to register whether           (1) The email address for the contact
                                                                                                          or not food from the facility enters                  person of a domestic facility and the
                                                  Registration of Food Facilities Under
                                                                                                          interstate commerce. Foreign facilities               email address of the United States agent
                                                  the Public Health Security and
                                                                                                          that manufacture/process, pack, or hold               for a foreign facility; (2) an assurance
                                                  Bioterrorism Preparedness and
                                                                                                          food also are required to register unless             that FDA will be permitted to inspect
                                                  Response Act of 2002—21 CFR 1.230 to
                                                                                                          food from that facility undergoes further             the facility; and (3) specific food
                                                  1.235 OMB Control Number 0910–
                                                                                                          processing (including packaging) by                   categories as identified in the guidance
                                                  0502—Extension
                                                                                                          another foreign facility outside the                  document entitled, ‘‘Guidance for
                                                    The Public Health Security and                        United States. However, if the further                Industry: Necessity of the Use of Food
                                                  Bioterrorism Preparedness and                           manufacturing/processing conducted by                 Product Categories in Food Facility
                                                  Response Act of 2002 (the Bioterrorism                  the subsequent facility consists of                   Registrations and Updates to Food
                                                  Act) added section 415 to the Federal                   adding labeling or any similar activity of            Product Categories’’ (section 415(a)(2) of
                                                  Food, Drug, and Cosmetic Act (the                       a de minimis nature, the former facility              the FD&C Act 21 U.S.C. 350d(a)(2)).
                                                  FD&C Act) (21 U.S.C. 350d), which                       is required to register.                                 Food Facility Registration, in
                                                  requires domestic and foreign facilities                   Information FDA requires on the                    conjunction with advance notice of
                                                  that manufacture, process, pack, or hold                registration form includes the name and               imported food, helps FDA act quickly in
                                                  food for human or animal consumption                    full address of the facility; emergency               responding to a threatened or actual
                                                  in the United States to register with                   contact information; all trade names the              bioterrorist attack on the U.S. food
                                                  FDA. Sections 1.230 to 1.235 of FDA’s                   facility uses; applicable food product                supply or to other food-related
                                                  regulations (21 CFR 1.230 to 1.235) set                 categories; and a certification statement             emergencies. Food Facility Registration
                                                  forth the procedures for registration of                that includes the name of the individual              provides FDA with information about
                                                  food facilities. Information provided to                authorized to submit the registration                 facilities that manufacture/process,
                                                  FDA under these regulations helps the                   form. Additionally, facilities are                    pack, or hold food for consumption in
                                                  agency to notify quickly the facilities                 encouraged to submit their preferred                  the United States. In the event of an
                                                  that might be affected by a deliberate or               mailing address; type of activity                     outbreak of foodborne illness, such
                                                  accidental contamination of the food                    conducted at the facility; type of storage,           information helps FDA and other
                                                  supply. In addition, data collected                     if the facility is primarily a holding                authorities determine the source and
                                                  through registration is used to support                 facility; and approximate dates of                    cause of the event. In addition, the
                                                  FDA enforcement activities and to                       operation if the facility’s business is               registration information enables FDA to
                                                  screen imported food shipments.                         seasonal.                                             notify more quickly the facilities that
                                                  Advance notice of imported food allows                     In addition to registering, a facility is          might be affected by the outbreak. See
                                                  FDA, with the support of the Bureau of                  required to submit timely updates                     Interim Final Rule entitled,
                                                  Customs and Border Protection, to target                within 60 days of a change to any                     ‘‘Registration of Food Facilities Under
                                                  import inspections more effectively and                 required information on its registration              the Public Health Security and
                                                  help protect the nation’s food supply                   form, using Form FDA 3537 (§ 1.234),                  Bioterrorism Preparedness and
                                                  against terrorist acts and other public                 and to cancel its registration when the               Response Act of 2002’’ (68 FR 58894, at
                                                  health emergencies. If a facility is not                facility ceases to operate or is sold to              58895; October 10, 2003).
                                                  registered or the registration for a                    new owners or ceases to manufacture/
                                                  facility is not updated when necessary,                 process, pack, or hold food for                          Implementation of the FSMA
                                                  FDA may not be able to contact the                      consumption in the United States, using               requirements described previously
                                                  facility and may not be able to target                  Form FDA 3537a (§ 1.235).                             helps enable FDA to quickly identify
                                                  import inspections effectively in case of                  The FDA Food Safety Modernization                  and remove from commerce an article of
                                                  a known or potential threat to the food                 Act (FSMA) (Pub. L. 111–353) amended                  food for which there is a reasonable
                                                  supply or other food-related emergency,                 section 415 of the FD&C Act in relevant               probability that the use of, or exposure
                                                  putting consumers at risk of consuming                  part to require registrants for food                  to, such article of food will cause
                                                  hazardous food products that could                      facilities to submit additional                       serious adverse health consequences or
                                                  cause serious adverse health                            registration information to FDA, and to               death to humans or animals. FDA uses
                                                  consequences or death.                                  require facilities required to register               the information collected under these
                                                    FDA’s regulations require that each                   with FDA to renew such registrations                  provisions to help ensure that such food
                                                  facility that manufactures, processes,                  biennially. Section 415(a)(2) of the                  products are quickly and efficiently
                                                  packs, or holds food for human or                       FD&C Act, as amended by FSMA, also                    removed from the market.
                                                  animal consumption in the United                        provides that, when determined                           Description of Respondents:
                                                  States register with FDA using Form                     necessary by FDA ‘‘through guidance,’’                Respondents to this collection of
                                                  FDA 3537 (§ 1.231), unless exempt                       a food facility is required to submit to              information are owners, operators, or
                                                  under 21 CFR 1.226 from the                             FDA information about the general food                agents in charge of domestic or foreign
                                                  requirement to register. The term ‘‘Form                category of a food manufactured,                      facilities that manufacture, process,
                                                  FDA 3537’’ refers to both the paper                     processed, packed or held at such                     pack, or hold food for human or animal
                                                  version of the form and the electronic                  facility, as determined appropriate by                consumption in the United States.
                                                  system known as the Food Facility                       FDA, including by guidance. The                          FDA estimates the burden of this
                                                  Registration Module, which is available                 modified food facility registration forms             collection of information as follows:
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                                                  27142                             Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices

                                                                                                  TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                              Number of                                                Average
                                                   21 CFR section and/or section of FD&C                  FDA form                 Number of                                            Total annual
                                                                                                                                                            responses per                                            burden per              Total hours
                                                                    Act                                    number                 respondents                                            responses
                                                                                                                                                              respondent                                              response

                                                                                                                                       New Facilities

                                                                                                                                            Domestic

                                                  §§ 1.230 to 1.233 and section 415 of the                 FDA 3537 2                         11,080                             1                  11,080        2.7 ..................           29,916
                                                    FD&C Act.

                                                                                                                                             Foreign

                                                  §§ 1.230 to 1.233 and section 415 of the                   FDA 3537                         19,900                             1                  19,900        8.9 ..................         177,110
                                                    FD&C Act.

                                                       New Facility Registration Subtotal ...         ........................   ........................   ........................   ........................   ........................       207,026

                                                                                                                         Previously Registered Facilities

                                                  Updates under § 1.234 and section 415                      FDA 3537                       118,530                              1                118,530         1.2 ..................         142,236
                                                    of the FD&C Act.
                                                  Cancellations under § 1.235 ....................         FDA 3537a                          6,390                               1                 6,390         1 .....................           6,390
                                                  Biennial renewal of registration required                 FDA 3537                        104,786                               1               104,786         0.50 (30 mins.)                  52,393
                                                    by section 415 of the FD&C Act.

                                                       Updates, Cancellations, or Biennial            ........................   ........................   ........................   ........................   ........................       201,019
                                                         Renewals Subtotal.

                                                             Total Hours Annually .................   ........................   ........................   ........................   ........................   ........................       408,045
                                                     1 There
                                                           are no capital costs or operating and maintenance costs associated with this collection of information.
                                                     2 The
                                                         term ‘‘Form FDA 3537’’ refers to both the paper version of the form and the electronic system known as the Food Facility Registration
                                                  Module, which is available at http://www.access.fda.gov.


                                                    This estimate is based on FDA’s                           burden of approximately 8.5 hours per                                        calculated to be 142,236 hours (118,530
                                                  experience and the average number of                        average foreign facility registration. We                                    × 1.2 hours).
                                                  new facility registrations, updates and                     estimate that the FSMA-required                                                 Based on FDA’s experience, we
                                                  cancellations received in the past 3                        additional information for new facility                                      estimate that the average annual number
                                                  years. Based on this experience, we                         registrations will require an additional                                     of cancellations of facility registrations
                                                  estimate the annual number of new                           24 minutes (0.4 hour) per response for                                       will remain unchanged at 6,390
                                                  domestic facility registrations will be                     foreign facilities. The average foreign                                      cancellations annually over the next 3
                                                  11,080. We estimate that listing the                        facility burden hour estimate of 8.9                                         years. We also estimate that cancelling
                                                  information required by the                                 hours includes an estimate of the                                            a registration will, on average, require a
                                                  Bioterrorism Act and presenting it in a                     additional burden on a foreign facility to                                   burden of approximately 1 hour, taking
                                                  format that will meet the Agency’s                          obtain a U.S. agent, and takes into                                          into account fluency in English and
                                                  registration regulations will require a                     account that for some foreign facilities                                     Internet access. FSMA did not change
                                                  burden of approximately 2.5 hours per                       the respondent completing the                                                the required information for
                                                  average domestic facility registration.                     registration may not be fluent in English                                    cancellations. Thus, the total annual
                                                  We estimate that the FSMA-required                          and/or not have readily available
                                                  additional information for new facility                                                                                                  burden for cancelling registrations is
                                                                                                              Internet access. Thus, the total annual                                      estimated to be 6,390 hours.
                                                  registrations will require an additional                    burden for new foreign facility
                                                  12 minutes (0.2 hour) per response for                                                                                                      We estimate that the new biennial
                                                                                                              registrations is calculated to be 177,110
                                                  domestic facilities. The average                                                                                                         registration required by FSMA, which
                                                                                                              hours (19,900 × 8.9 hours).                                                  will require the submission of certain
                                                  domestic facility burden hour estimate
                                                  of 2.7 hours takes into account that                          Based on FDA’s experience, we                                              new data elements and the verification
                                                  some respondents completing the                             estimate that the average annual number                                      and possible updating of other
                                                  registration may not have readily                           of updates to facility registrations will                                    information rather than re-entering all
                                                  available Internet access. Thus, the total                  remain unchanged at 118,530 updates                                          information, will require 30 minutes
                                                  annual burden for new domestic facility                     annually over the next 3 years. We also                                      (0.5 hour) per response, including time
                                                  registrations is calculated to be 29,916                    estimate that updating a registration                                        for the new FSMA-required information.
                                                  hours (11,080 × 2.7 hours).                                 will, on average, require a burden of                                        We estimate that, on an annualized
                                                    Based on FDA’s experience, we                             approximately 1 hour, taking into                                            basis, the number of biennial
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                                                  estimate the annual number of new                           account fluency in English and Internet                                      registrations submitted over the next 3
                                                  foreign facility registrations will be                      access. We estimate that the FSMA-                                           years will be 104,786. This estimate is
                                                  19,900. We estimate that listing the                        required additional information for                                          based on the number of currently
                                                  information required by the                                 updates will require an additional 12                                        registered firms (209,573) divided by
                                                  Bioterrorism Act and presenting it in a                     minutes (0.2 hour) per response. Thus,                                       two. Thus, the total annual burden for
                                                  format that will meet the Agency’s                          the total annual burden of submitting                                        biennial registration is calculated to be
                                                  registration regulations will require a                     updates to facility registrations is                                         52,393 hours (104,786 × 0.5 hours).


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                                                                                  Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Notices                                            27143

                                                    Dated: May 2, 2016.                                     Period of Performance: July 1, 2016, to             assignment of National Health Service
                                                  Leslie Kux,                                             June 30, 2017.                                        Corps (NHSC) scholarship recipients
                                                  Associate Commissioner for Policy.                        Intended Recipient of the Award:                    available for service during the period
                                                  [FR Doc. 2016–10559 Filed 5–4–16; 8:45 am]              National Alliance of State and                        October 1, 2016, through September 30,
                                                  BILLING CODE 4164–01–P
                                                                                                          Territorial AIDS Directors.                           2017, is posted on the NHSC Jobs Center
                                                                                                            Amount of Non-Competitive Award:                    Web site at http://nhscjobs.hrsa.gov.
                                                                                                          $900,000.                                             The NHSC Jobs Center includes sites
                                                  DEPARTMENT OF HEALTH AND                                  CFDA Number: 93.145.                                that are approved for performance of
                                                  HUMAN SERVICES                                                                                                service by NHSC scholars; however,
                                                                                                            Authority: Sections 2606, 2654, 2671, and           note that entities on this list may or may
                                                                                                          2692 of Title XXVI of the Public Health
                                                  Health Resources and Services                                                                                 not have current job vacancies.
                                                                                                          Service Act, as amended by the Ryan White
                                                  Administration                                          HIV/AIDS Treatment Extension Act of 2009              Eligible HPSAs and Entities
                                                                                                          (Pub. L. 111–87)
                                                  Ryan White HIV/AIDS Program                                                                                      To be eligible to receive assignment of
                                                  Resource and Technical Assistance                          Justification: The National Alliance of            Corps members, entities must: (1) Have
                                                  Center for HIV Prevention and Care for                  State and Territorial AIDS Directors has              a current HPSA status of ‘‘designated’’
                                                  Black MSM                                               been very successful at collecting,                   by the Division of Policy and Shortage
                                                                                                          developing, and analyzing clinical                    Designation, Bureau of Health
                                                  AGENCY:  Health Resources and Services                  models of care and best practices for                 Workforce, HRSA, as of January 1, 2016,
                                                  Administration, HHS.                                    HIV care and treatment. Additional time               for placements October 1, 2016, through
                                                  ACTION: Notice of deviation from                        is needed to complete analyses and                    December 31, 2016, or as of January 1,
                                                  competition requirements for Ryan                       disseminate them across the country to                2017, for placements January 1, 2017,
                                                  White HIV/AIDS Program (RWHAP)                          grant recipients, health centers, and HIV             through September 30, 2017; (2) not
                                                  Resource and Technical Assistance                       stakeholder communities. This funding                 deny requested health care services or
                                                  Center for HIV Prevention and Care for                  reflects the amount needed to complete                discriminate in the provision of services
                                                  Black men who have sex with men                         the final phase of program activities,                to an individual because the individual
                                                  (MSM) (Grant#U69HA27173).                               which is the dissemination of models                  is unable to pay for the services, because
                                                                                                          and best practices for HIV treatment and              payment for the services would be made
                                                  SUMMARY:   The HIV/AIDS Bureau (HAB)                    care through Ryan White Part C and D                  under Medicare, Medicaid, or the
                                                  is requesting a deviation from the                      grant recipients, AIDS Education and                  Children’s Health Insurance Program
                                                  competition requirements in order to                    Training Centers, and HRSA Bureau of                  (CHIP), or based upon the individual’s
                                                  provide a 1 year extension with funds                   Primary Health Care Health Centers to                 race, color, sex, national origin,
                                                  to the Resource and Technical                           improve engagement of and retention in                disability, religion, age, or sexual
                                                  Assistance Center for HIV Prevention                    care for young Black MSM, one of the                  orientation; (3) enter into an agreement
                                                  and Care for Black MSM cooperative                      highest risk populations identified in                with the state agency that administers
                                                  agreement recipient, the National                       the National HIV/AIDS Strategy for HIV                Medicaid and CHIP, accept assignment
                                                  Alliance of State and Territorial AIDS                  transmission. The aim and purpose of                  under Medicare, see all patients
                                                  Directors. The purpose of the program is                dissemination of these interventions is               regardless of their ability to pay and
                                                  to develop a Resource and Technical                     to increase the capacity, quality, and                post such policy, and use and post a
                                                  Assistance Center for HIV prevention                    effectiveness of HIV/AIDS service                     discounted fee plan; and (4) be
                                                  and care of models and interventions                    providers to screen, diagnose, link, and              determined by the Secretary to have (a)
                                                  that increase the capacity, quality, and                retain the adult and young Black MSM                  a need and demand for health
                                                  effectiveness of HIV/AIDS service                       community in HIV clinical care.                       manpower in the area; (b) appropriately
                                                  providers to screen, diagnose, link, and                                                                      and efficiently used Corps members
                                                                                                            Dated: April 29, 2016.
                                                  retain, the adult and young Black MSM                                                                         assigned to the entity in the past; (c)
                                                                                                          James Macrae,
                                                  community in HIV clinical care. The 2-                                                                        general community support for the
                                                                                                          Acting Administrator.                                 assignment of Corps members; (d) made
                                                  year project period ends June 30, 2016.
                                                                                                          [FR Doc. 2016–10533 Filed 5–4–16; 8:45 am]            unsuccessful efforts to recruit health
                                                  The extension through June 30, 2017,
                                                  for this project provides necessary                     BILLING CODE 4165–15–P                                professionals; (e) a reasonable prospect
                                                  funding and time to complete                                                                                  for sound fiscal management by the
                                                  previously approved project activities,                                                                       entity with respect to Corps members
                                                                                                          DEPARTMENT OF HEALTH AND                              assigned there; and (f) demonstrated a
                                                  an orderly phase out, and transition to
                                                                                                          HUMAN SERVICES                                        willingness to support and facilitate
                                                  the next stage of evaluation for the
                                                  models of HIV clinical care and best                                                                          mentorship, professional development,
                                                                                                          Health Resources and Services                         and training opportunities for Corps
                                                  practices needed for HIV viral                          Administration
                                                  suppression. The next stage of planning                                                                       members.
                                                  by HAB is to use the models, tools, and                                                                          Priority in approving applications for
                                                                                                          Recruitment of Sites for Assignment of
                                                  best practices developed for improved                                                                         assignment of Corps members goes to
                                                                                                          Corps Personnel Obligated Under the
                                                  health outcomes by this recipient for                                                                         sites that (1) provide primary medical
                                                                                                          National Health Service Corps
                                                  fiscal year 2017 competitive funding                                                                          care, mental health, and/or oral health
                                                                                                          Scholarship Program
                                                  under the HAB Special Projects of                                                                             services that matches the discipline to a
                                                                                                                                                                primary medical care, mental health, or
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                                                  National Significance Program.                          AGENCY: Health Resources and Services
                                                                                                          Administration (HRSA), HHS.                           dental HPSA of greatest shortage,
                                                  FOR FURTHER INFORMATION CONTACT:                                                                              respectively; (2) are part of a system of
                                                                                                          ACTION: General notice.
                                                  Antigone Dempsey, Director, Division of                                                                       care that provides a continuum of
                                                  Policy and Data, HRSA/HAB/DPD, 5600                     SUMMARY:    HRSA announces that the                   services, including comprehensive
                                                  Fishers Lane, Rockville, MD 20857,                      listing of entities, and associated Health            primary health care and appropriate
                                                  email: adempsey@hrsa.gov.                               Professional Shortage Area (HPSA)                     referrals (e.g., ancillary, inpatient, and
                                                  SUPPLEMENTARY INFORMATION:                              scores, that will receive priority for the            specialty referrals) or arrangements for


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Document Created: 2016-05-05 01:15:31
Document Modified: 2016-05-05 01:15:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by July 5, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 27140 

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